Clinical Trials /

Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)

NCT02893332

Description:

To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.

Related Conditions:
  • Lung Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)
  • Official Title: Tyrosine-kinase Inhibitor (TKI) With or Without SBRT in Newly Diagnosed Advanced Staged Lung Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: 2016 15-1
  • NCT ID: NCT02893332

Conditions

  • Stage IV EGFR Mutated Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
TKI (Gefitinib or Tarceva )TKI without SBRT

Purpose

To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.

Detailed Description

      This protocol is a randomized phase III trial of TKI versus consolidative Stereotactic Body
      Radiation Therapy (SBRT) plus TKI for patients with Stage IV non-small cell lung cancer
      (NSCLC).

      Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with positive
      EGFR mutation. Patients who with fewer than or equal to 5 sites of oligometastatic disease
      will be randomized toTKI or consolidative SBRT to all sites of disease (followed by TKI at
      the medical oncologist's discretion). Choices of TKI will be determined by the medical
      oncologist based on clinical appropriateness.
    

Trial Arms

NameTypeDescriptionInterventions
TKI without SBRTActive ComparatorNewly diagnosed Patients will be placed on EGFR-TKI, ,Gefitinib 250mg po qd or Tarceva 150mg po qd for their metastatic EGFR-mutant stage IV oligometastatic disease. The oligometastatic disease will not receive SBRT
  • TKI (Gefitinib or Tarceva )
TKI with SBRTExperimentalexperimental: Oligometastatic Non-Small Cell Lung Cancer Newly diagnosed patients will be placed on EGFR-TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, and SBRT at the same time. SBRT to up to 5 sites. The SBRT dose range from 5 Gy per fraction to 8 Gy per fraction. SBRT deliver within 5 fractions.
  • TKI (Gefitinib or Tarceva )

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring
             sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19
             insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective
             of location, inclusive of the primary lesion):

               -  all sites of disease must be amenable to definitive treatment with a local
                  therapy (surgical resection, stereotactic radiosurgery, ablation and conventional
                  radiation therapy) as determined by surgery, interventional radiology and
                  radiation oncology

               -  all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular
                  nodal disease) are considered 1 discrete lesion.

          -  Each brain metastasis is included as a distinct lesion.

          -  Patients already started on erlotinib are eligible as long as their sites of disease
             are determined to be eligible for definitive local therapy by consensus of the
             principal investigators within 12 weeks of the patient first taking erlotinib.

          -  Lung adenocarcinoma histology confirmed

          -  Karnofsky Performance Status ≥ 70%

          -  Adequate bone marrow, liver and renal function, as specified below:

               -  Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L

               -  Hemoglobin ≥ 8 g/dL

               -  Platelets ≥ 100 x 109/L

               -  Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients
                  with documented Gilbert's Syndrome)

               -  AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present

               -  Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min
                  for patients with creatinine levels above institutional normal.

          -  For women of child-bearing potential, negative pregnancy test within 14 days prior to
             starting treatment

          -  Men and women of childbearing age must be willing to use effective contraception while
             on treatment and for at least 3 months thereafter

        Exclusion Criteria:

          -  Treatment with TKI prior to developing metastatic disease

          -  Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR
             T790M)

          -  Malignant pleural effusion or pleural disease

          -  Leptomeningeal disease

          -  Any site of disease that is not amenable to definitively local therapy including
             surgery or radiation therapy

          -  Women who are breastfeeding or pregnant

          -  Concurrent malignancies other than non-melanoma skin cancer that require active
             ongoing treatment.

          -  Any medical co-morbidities that would preclude surgery or radiation therapy
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival
Time Frame:4 years
Safety Issue:
Description:Evaluate the effect of TKI with or without SBRT on progression free survival

Secondary Outcome Measures

Measure:local control
Time Frame:4 years
Safety Issue:
Description:To describe local control and out-of-field disease progression
Measure:Overall survival
Time Frame:4 years
Safety Issue:
Description:To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sichuan Provincial People's Hospital

Last Updated

April 16, 2018